Pfizer's Inlyta fails to prolong disease-free survival in Phase III study of patients at risk of recurrent kidney cancer

Pfizer on Tuesday announced that it will halt a late-stage study evaluating Inlyta (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy. The decision, made following a recommendation by an independent Data Monitoring Committee, comes after an interim analysis showed the drug did not extend disease-free survival versus placebo. Mace Rothenberg, chief development officer of oncology at Pfizer's global product development unit, said "we are disappointed by the outcome of this study as we had hoped the efficacy that Inlyta has demonstrated as a second-line treatment in patients with advanced RCC would carry over to patients with earlier-stage disease." 

The ATLAS study, conducted in partnership with SFJ Pharmaceuticals, enrolled 724 patients at high risk of recurrent RCC following nephrectomy who were randomised to receive adjuvant Inlyta or placebo. The primary endpoint of the trial was disease-free survival. Pfizer said detailed ATLAS results will be submitted for presentation at a future medical meeting.

"We will conduct additional analyses on the data that may provide insight into this result," Rothenberg stated, noting that "studies evaluating Inlyta in combination with immune checkpoint inhibitors for patients with a variety of advanced-stage cancers, including RCC, will continue." 

Inlyta was approved in the US in 2012 for the treatment of patients with advanced RCC following the failure of first-line systemic therapy. The drug was also later cleared by the European Commission for use in adults with advanced RCC after the failure of prior treatment with Pfizer's Sutent (sunitinib) or a cytokine. 

Register as Visitor to CPhI China 2018!